> Markdown version of [/jobs/ext/2984496-statistical-programmer](https://www.wearedevelopers.com/jobs/ext/2984496-statistical-programmer). Every page supports `.md` or `Accept: text/markdown`. Links point to the HTML versions so they work for humans too. Agent guide: [/agents.md](https://www.wearedevelopers.com/agents.md). --- # Statistical Programmer - **Company:** Cencora - **Location:** Barcelona, Spain (Remote available) - **Contract:** Permanent contract - **Skills:** Data Analysis, Application Integration Architecture, Clinical Data Repository, Data Files, Data Governance, Data Integration, Software Debugging, Scrum Methodology, SAS (Software), Data Management - **Published:** September 18, 2026 - **Apply:** https://www.adzuna.es/contact-us.html ## About the Role + Master's degree in Statistics, Biostatistics, Data Science, or a related quantitative field with 6+ years of experience; or Bachelor's degree in the same fields with 8+ years of experience, in clinical statistical programming within the pharmaceutical, biotechnology, or CRO industry, with demonstrable hands-on regulatory submission work + Expert-level proficiency in CDISC-compliant statistical programming in SAS, including development of SDTM and ADaM datasets from raw clinical data, with a strong understanding of CDISC Implementation Guides (SDTMIG, ADaMIG). + Proven experience supporting regulatory submissions (eCTD), including preparation of SDTM/ADaM datasets, Define.xml, SDRG, ADRG, TFLs, and submission documentation aligned with FDA and EMA expectations. experience authoring or contributing to a Study Data Standardization Plan (SDSP) is preferred and a plus. + Proven experience in the creation of macro libraries, format catalogs, enhanced visual output displays, training presentations, SOPs, and other documentation. + Excellent organizational, project management, and written and verbal communication skills are required. Ability to work well with a wide range of internal and external stakeholders and build strong partnerships inside and outside the organization. + Comfortable working across multiple phases of clinical development and able to shift gears quickly. Must be open to change and the unknown with a creative and resourceful nature; a self-starter, proactive and results-oriented with high performance standards. + Ability to manage multiple projects and meet deadlines in a fast-paced environment. + Advanced SAS programming skills are required; proficiency or active development in R is strongly preferred. + Strong understanding of clinical trial design, data analysis, and regulatory requirements. + Excellent problem-solving skills and attention to detail. + Strong communication and interpersonal skills, with the ability to guide diverse groups of people through complex processes in a team environment. Preferred Qualifications: + Experience with SDSP, SDRG, or ADRG as primary author beyond execution-level contribution is a strong plus. + Experience with cross-study data integration (e.g., in ISS/ISE) is a strong plus. + Experience with Standard for Exchange of Nonclinical Data (SEND) is a plus. + Experience of working with international teams remotely is a plus. + Experience in management, Agile/scrum-type experience is a plus. + Statistical background or knowledge is a plus ## Description We are seeking a highly skilled Senior Statistical Programmer with extensive experience in CDISC-compliant statistical programming. The Statistical Programmer will act as a subject matter expert (SME) in CDISC data standards and a project manager responsible for coordinating the preparation, execution, reporting and documentation of statistical programming activities internally and externally. This role requires deep expertise in CDISC-compliant programming, thorough understanding of regulatory submission requirements of data packages, and the ability to act as programming project lead across internal and external teams., + Lead and contribute to the development, review, and documentation of CDISC-compliant dataset specifications and data sets, with primary focus on SDTM and ADaM; serve as an SME for CDISC standards governance. + Perform quality control (QC) of CDISC dataset specifications, derived datasets, and standard or custom tables, figures, and listings (TFLs) to ensure quality and compliance with CDISC standards and regulatory guidelines. + Generate or review TFLs for clinical study reports and regulatory submissions. + Perform statistical programming using SAS and R, ensuring compliance with CDISC standards. + Prepare submission-ready regulatory documentation including Define.xml, Study Data Reviewer's Guide (SDRG), Analysis Data Reviewer's Guide (ADRG), and other documentation as required (e.g., ISS/ISE), in alignment with regulatory authority expectations (e.g., FDA, EMA). + Contribute to process optimization (e.g., SAS macro libraries, code or documentation templates, standard operating procedures (SOPs)), development of a modern programming ecosystem (e.g., R adoption, automation, AI integration), and internal training development and delivery to build a consistent, scalable internal CDISC programming infrastructure. + Provide technical support to other team members to ensure that they have the required knowledge to fulfil their duties. + Work collaboratively with statisticians and/or Data Management function to resolve all data issues arising and to document outcomes. + Perform any other related activities assigned by the supervisor and participate in task forces/initiatives. + Validating/debugging the codes written by other team members. + Maintain quality and timeliness of project work. ## Related Videos - [Times of (climate) crisis - How and why sustainable software is a must!](https://www.wearedevelopers.com/videos/988-times-of-climate-crisis-how-and-why-sustainable-software-is-a-must) - [Data Science in Retail](https://www.wearedevelopers.com/videos/586-data-science-in-retail) - [Data Science on Software Data](https://www.wearedevelopers.com/videos/162-data-science-on-software-data) - [Introduction to TXT](https://www.wearedevelopers.com/videos/30-introduction-to-txt) - [One Pipeline, Three Regulator - SBOM Compliance for the Developer](https://www.wearedevelopers.com/videos/100169-one-pipeline-three-regulator-sbom-compliance-for-the-developer) - [Reporting Active Exploits in 24 Hours: Are You Ready for the CRA?](https://www.wearedevelopers.com/videos/100248-reporting-active-exploits-in-24-hours-are-you-ready-for-the-cra) ## Related Articles - [Résumé-Driven Development: How IT trends affect the job market for software developers](https://www.wearedevelopers.com/magazine/59-resume-driven-development-how-it-trends-affect-the-job-market-for-software-developers) - [The 12 Best Jobs for Software Engineers](https://www.wearedevelopers.com/magazine/401-the-12-best-jobs-for-software-engineers) - [Data Analyst Salary in the UK](https://www.wearedevelopers.com/magazine/278-data-analyst-salary-in-the-uk) - [Fully Remote Software Engineer Jobs](https://www.wearedevelopers.com/magazine/447-fully-remote-software-engineer-jobs) - [How We Built a Worry-Free System That Runs for 10+ Years – And What We’d Do Again](https://www.wearedevelopers.com/magazine/751-how-we-built-a-worry-free-system-that-runs-for-10-years-and-what-we-d-do-again) - [Data Engineer Salary UK](https://www.wearedevelopers.com/magazine/253-data-engineer-salary-uk)